reclast

Generic: zoledronic acid

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name reclast
Generic Name zoledronic acid
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 5 mg/100mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 66758-155
Product ID 66758-155_12a00376-75c0-41e4-b0a5-d8adb81a3cc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021817
Listing Expiration 2027-12-31
Marketing Start 2007-04-01

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66758155
Hyphenated Format 66758-155

Supplemental Identifiers

RxCUI
705824 705875
UNII
6XC1PAD3KF

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name reclast (source: ndc)
Generic Name zoledronic acid (source: ndc)
Application Number NDA021817 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/100mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (66758-155-46)
source: ndc

Packages (1)

66758-155-46 100 mL in 1 BOTTLE (66758-155-46)

Ingredients (1)

zoledronic acid (5 mg/100mL)

Linked Drug Pages (1)

Reclast ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "12a00376-75c0-41e4-b0a5-d8adb81a3cc4", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["705824", "705875"], "spl_set_id": ["5a9b3737-9ce6-4a89-b76e-6aab79eba9cf"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (66758-155-46)", "package_ndc": "66758-155-46", "marketing_start_date": "20241218"}], "brand_name": "Reclast", "product_id": "66758-155_12a00376-75c0-41e4-b0a5-d8adb81a3cc4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "66758-155", "generic_name": "zoledronic acid", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Reclast", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "5 mg/100mL"}], "application_number": "NDA021817", "marketing_category": "NDA", "marketing_start_date": "20070401", "listing_expiration_date": "20271231"}